Inovytec Ventway Sparrow User Manual

Inovytec Ventway Sparrow User Manual

Civil and military model. emergency and transport ventilator
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User Manual
Ventway Sparrow
Emergency and transport
ventilator
VWSP-100 Civil Model
VWSP-900 Military Model
Document Number VWSP-500-03
October 2018

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Summary of Contents for Inovytec Ventway Sparrow

  • Page 1 User Manual Ventway Sparrow Emergency and transport ventilator VWSP-100 Civil Model VWSP-900 Military Model Document Number VWSP-500-03 October 2018...
  • Page 2 Inovytec Medical Solutions Ltd. Inovytec Medical Solutions Ltd. reserves the right to change or improve its products and accompanying technical literature without specific notice of changes or improvements.
  • Page 3 FDA Tracking Requirements U.S. Federal Law (21 CFR 821) requires the tracking of ventilators. Under this law, owners of this ventilator must notify Inovytec Medical Solutions Ltd. if this product is received; lost, stolen, or destroyed; donated or resold; or otherwise distributed to a different organization.
  • Page 4: Table Of Contents

    YMBOLS USED IN THE SYSTEM 8.6. S ........................30 YSTEM NDICATORS 8.6.1. Battery Status ......................30 8.6.2. indicators ........................31 8.6.3. Alert ..........................31 9. Getting Started with Ventway Sparrow ................. 32 9.1. D ........................ 32 ISCONNECT PATIENT 9.2. P ........................33 ATIENT EIGHT 9.3.
  • Page 5 Ventway Sparrow User Manual 10.1. M )............39 ATIENT ISCONNECT ATIENT CREEN 10.2. M ....................39 ARAMS 10.2.1. MAIN MENU/Vent Params/Trigger Sensitivity ............40 10.2.2. MAIN MENU/Vent Params/Vent Mode ..............40 10.2.3. MAIN MENU/Vent Params/O Enrichment ..............40 10.2.4. MAIN MENU/Vent Params/Patient Weight ............... 40 10.3.
  • Page 6 Ventway Sparrow User Manual 15.2. CPAP – S ................... 66 PONTANEOUS BREATHING MODE 15.3. B ....................69 ACKUP ENTILATION 15.3.1. Backup Ventilation in CPAP ..................69 15.3.2. Backup Ventilation before starting patient ventilation ..........70 15.4. SIMV VC (CPR) ........................72 15.5.
  • Page 7 Ventway Sparrow User Manual 24.21. A ..................... 107 LTITUDE HANGE ALERT 24.22. S ......................108 HUTDOWN ALERT 24.23. V ) .......... 109 ENTILATION DURING STANDBY DUE TO PATIENT INSPIRATORY EFFORT 25. Appendix – Menu Hierarchy ....................110 Page 7 of 110...
  • Page 8 Inovytec distributor, please contact your distributor directly to report the problem. Note: If this ventilator has not been purchased directly from Inovytec, please ensure that it has been purchased from an authorized distributor of Inovytec. To obtain a list authorized distributors, contact Inovytec sales@Inovytec.com.
  • Page 9: About This User Manual

    Ventway Sparrow User Manual 1. ABOUT THIS USER MANUAL This User Manual provides the information necessary to operate and maintain the Ventway Sparrow ventilator. PLEASE READ THIS USER MANUAL BEFORE OPERATING THE SYSTEM. If any part of this User Manual is not clear, contact Customer Support for assistance.
  • Page 10: Glossary And Abbreviations

    Ventway Sparrow User Manual 1.2. GLOSSARY AND ABBREVIATIONS Apnea Temporary cessation of breathing Breaths Per Minute CPAP Continuous Positive Airway Pressure Liters per minute Mandatory Ventilator initiated breath Breath Minute Volume Non-Invasive Ventilation Peak Flow Maximum volumetric flow PEEP Peak End Expiratory Pressure...
  • Page 11: Overview Of System

    Ventway Sparrow User Manual 2. OVERVIEW OF SYSTEM 2.1. DESCRIPTION OF DEVICE The Ventway is an emergency portable ventilator, used for transport, EMS and military applications. The situations for which it is intended are characterized by attendance of first responders with limited triage capabilities, requiring a simple yet highly effective ventilator, that is self-sufficient and lightweight.
  • Page 12: Conditions For Use

    3. CONDITIONS FOR USE 3.1. INTENDED USE The Ventway Sparrow lung ventilator is intended for emergency use and transportation of adult and pediatric patients weighing at least 5 kg (11 lb). It may be used for invasive or noninvasive ventilation presets. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
  • Page 13: Contraindications

    Ventway Sparrow User Manual 3.3. CONTRAINDICATIONS  See specific patient instructions regarding performing ventilation or any use of life support equipment.  Acute Pneumothorax 3.4. LIMITATIONS OF USE Clinical situations potentially affecting accuracy or performance:  Controlling the flow in the presence of difficult airways, such as severe lung blockage and asymmetric air entrance to the lung ...
  • Page 14: Safety

    DO NOT USE BEFORE READING THIS USER MANUAL. DO NOT use this device for any purpose other than specified in this manual without written consent and approval from Inovytec Medical Solutions Ltd. In case of VENTILATOR failure, the lack of immediate access to appropriate alternative means of ventilation can result in PATIENT death.
  • Page 15 Ventway Sparrow User Manual Cautions If the device packaging is not intact, do not use the device. If the device does not turn on, or is not working correctly, discontinue use. Refer servicing or replacement to qualified service personnel. Do not disassemble any part of the system components. This system is not user-serviceable.
  • Page 16 Cautions Repairs should be undertaken only by personnel trained or auth- orized by Inovytec Medical Solutions Ltd. Do not modify this equip- ment without authorization from Inovytec Medical Solutions Ltd. The device may not operate correctly if used or stored outside the relevant temperature or humidity ranges, as described in the per- formance specifications.
  • Page 17 The contents of this manual are subject to change without prior notice. The user or any technical personnel who are not formally authorized by Inovytec Medical Solutions Ltd. should not open the device under any circumstances. Opening the device could damage the unit and will void the warranty provided by Inovytec Medical Solutions Ltd.
  • Page 18: System Components

    Ventway Sparrow User Manual 5. SYSTEM COMPONENTS 5.1. UNPACKING THE DEVICE Package contents Ventway Sparrow ventilator User Manual and device documentation Battery pack - Inside ventilator battery compartment Power supply Page 18 of 110...
  • Page 19: Ventilator - Front Panel

    Ventway Sparrow User Manual 5.2. VENTILATOR – FRONT PANEL Front Panel: (1) control knob, (2) display, (3) control and sensing tubes port, (4) patient port 5.3. VENTILATOR – REAR PANEL Rear Pane: (1) Air/Low pressure oxygen inlet, (2) Power supply connector, (3) USB...
  • Page 20: Ventilator - Use Configuration

    Ventway Sparrow User Manual 5.4. VENTILATOR – USE CONFIGURATION During transport, the ventilator is recommended to be placed in a horizontal position. Page 20 of 110...
  • Page 21: Patient Circuit

    Ventway Sparrow User Manual 5.5. PATIENT CIRCUIT Diagram of patient circuit Patient circuits specifications Adult Pediatric Nominal overall length 180 / 240 cm 180 / 240 cm Internal volume 690 / 920 CC 318 /424 CC Inspiratory Resistance to flow 2.7 cmH2O @ 60...
  • Page 22: Pneumatic Section - Theory Of Operation

    Ventway Sparrow User Manual 5.6. PNEUMATIC SECTION – THEORY OF OPERATION Page 22 of 110 Page 22 of 110...
  • Page 23 Ventway Sparrow User Manual Explanation of Diagram Solenoid valves exhaust – scavenging of gas residue from the solenoids , passed to inlet to prevent oxygen buildup inside the enclosure. Manifold assembly – encapsulates all electromechanical control elements, membranes, valves and air tubes in one compact element.
  • Page 24 Ventway Sparrow User Manual Inspiratory (1) vs. Expiratory cycle During the inspiratory cycle, the exhalation valve membrane is closed, allowing the gas from the ventilator to be diverted to the patient. Once the inspiration cycle is complete, the membrane opens, allowing the gas from the patient to be exhaled through the exhalation valve.
  • Page 25: Connecting The Ventilator

    6. CONNECTING THE VENTILATOR 6.1. FRONT PANEL CONNECTIONS 1 Pressure and flow measurement port 2 Pressure measurement port 3 Expiratory valve port – control tube 4 Ventilator gas output 6.2. REAR PANEL CONNECTIONS Air inlet/Oxygen supply connector – Air inlet and oxygen connector to demand valve (see Section 12.1.1.1.
  • Page 26: Power On And Display Startup Screen

    Ventway Sparrow User Manual 7. POWER ON AND DISPLAY STARTUP SCREEN To start the system, press and hold the Power On button on the back panel for 3 seconds. Back panel indicating the Power On button 7.1. QUICK START In an emergency situation, Quick Start allows you to start the ventilator immediately, using preset default options.
  • Page 27 Ventway Sparrow User Manual After you confirm by selecting the check mark and pressing the control know, specify the Patient Type: Patient Type screen Now the ventilator will operate in Backup mode: Ventilator running after Quick Start For information on Backup Mode, see Section 15.3. Backup Ventilation Mode.
  • Page 28: Navigating The Gui Screens

    Ventway Sparrow User Manual 8. NAVIGATING THE GUI SCREENS 8.1. SELECTING SCREEN OPTIONS To navigate between the screen options, turn the control knob on the left side of the device. When the desired option has been marked by positioning the marker...
  • Page 29: Confirming Or Cancelling A Message

    Ventway Sparrow User Manual 8.4. CONFIRMING OR CANCELLING A MESSAGE When a message is displayed by the system that allows a confirm or cancel response, press Cancel ( ) to reject the action, or press Confirm ( ) to accept the action.
  • Page 30: System Indicators

    Ventway Sparrow User Manual 8.6. SYSTEM INDICATORS The top left corner of the display shows battery status and system indicators. 8.6.1. BATTERY STATUS No battery, external power source used Non-rechargeable battery, no external power source Non-rechargeable battery, external power source connected...
  • Page 31: Indicators

    Ventway Sparrow User Manual 8.6.2. INDICATORS Patient trigger detected Pressure sensors are currently being zeroed Note: While zeroing sensors, the ventilator will not detect patient triggers. The bottom left corner of the display shows the active alerts indicator. 8.6.3. ALERT Caution: It is the user’s responsibility to ensure that the alerts are working...
  • Page 32: Getting Started With Ventway Sparrow

    Circuit Verification test. Note: An emergency quick start can be performed if necessary. See Section 7.1. Quick Start. The first screen showing the Ventway Sparrow logo allows the user to identify whether the display is working properly. 9.1. DISCONNECT PATIENT...
  • Page 33: Patient Weight

    Ventway Sparrow User Manual Note: If the Main Menu is selected instead of OK, the START option will be unavailable, since the weight of the patient is unknown and ventilation parameters are not set. For details on the Main Menu option, see Section 10. Main Menu.
  • Page 34: Ventilation Mode

    Ventway Sparrow User Manual 9.3. VENTILATION MODE Select the initial choice of ventilation mode. This can be changed later. See Section 15. Ventilation Methods for details about each ventilation mode. Ventilation Mode screen After ventilation mode is selected, select Invasive or Non-Invasive Mode:...
  • Page 35: Ventilation Parameters

    Ventway Sparrow User Manual 9.4. VENTILATION PARAMETERS The Ventilation Parameters screen displays the relevant patient information , updated on a real-time basis: Manual Graph Breath Alerts Menu Ventilation Parameters screen  Select BPM to change the breaths per minute delivered.
  • Page 36: Numerical Representation Of Breath Parameters

    Ventway Sparrow User Manual 9.5. NUMERICAL REPRESENTATION OF BREATH PARAMETERS The measured and computed values that are displayed in the system are calculated using the filtering and smoothing techniques described below. Patient pressure is displayed to the user by a bar (graphic refreshment frequency is 10 Hz).
  • Page 37: Pressure And Flow Graphs

    Ventway Sparrow User Manual 9.6. PRESSURE AND FLOW GRAPHS This display shows the graphs of the pressure (in units of cmH2O) over time, and flow (in units of LPM) vs. time. Rotation of the knob will switch between flow and pressure graphs.
  • Page 38: Main Menu

    Ventway Sparrow User Manual 10. MAIN MENU The Main Menu screen allows the user to view and set various system values. Menu screen STOP VENT/START VENT Stop or start the respiratory function of the device. NEW PATIENT View the Disconnect Patient screen and reset all selected parameters. See Section 10.1.
  • Page 39: Main Menu/New Patient (Disconnect Patient Screen)

    Ventway Sparrow User Manual 10.1. MAIN MENU/NEW PATIENT (DISCONNECT PATIENT SCREEN) This screen allows the user to restart existing ventilation parameters, e.g. when ventilating a new patient. Disconnect Patient screen 10.2. MAIN MENU/VENT PARAMS These screens allow the user to set the patient weight, ventilation mode, and other ventilation parameters.
  • Page 40: Main Menu/Vent Params/Trigger Sensitivity

    Ventway Sparrow User Manual 10.2.1. MAIN MENU/VENT PARAMS/TRIGGER SENSITIVITY Set the trigger sensitivity for the pressure measurements. Trigger Sensitivity screen Caution: When closed suction catheterization is performed, patient trigger sensitivity must be turned to "off". Caution: During transport ventilation, when the patient is...
  • Page 41: Main Menu/Alert Settings

    See also Section 11. Warnings and Alerts for more information about warning and alert messages. Caution: Boot Fail Alert The Boot Fail screen appears if the system experiences an error when starting. Replace ventilator and contact Inovytec support. Boot Fail screen Page 41 of 110...
  • Page 42: Main Menu/Advanced Settings

    Ventway Sparrow User Manual 10.4. MAIN MENU/ADVANCED SETTINGS The Advanced Settings menu screen is shown below. Advanced Settings menu These options are explained in the following sections. 10.4.1. MAIN MENU/ADV SETTINGS/LOAD DEFAULT Set all parameters to their default values by the set weight.
  • Page 43: Main Menu/Adv Settings/Alert Volume

    Ventway Sparrow User Manual 10.4.3. MAIN MENU/ADV SETTINGS/ALERT VOLUME Change the volume of all sound cues of the system. 10.4.4. MAIN MENU/ADV SETTINGS/LANGUAGE Change the system display language. 10.4.5. MAIN MENU/ADV SETTINGS/TECH MODE Tech mode allows the setting of the time, total hours of operation, and provides a system self-test function.
  • Page 44: Main Menu/Adv Settings/Tech Mode/Set Time

    Ventway Sparrow User Manual 10.4.5.1. MAIN MENU/ADV SETTINGS/TECH MODE/SET TIME Set the system date and time. The Set Time screen 10.4.5.2. MAIN MENU/ADV SETTINGS/TECH MODE/CALIBRATION Under Tech mode, the user may perform volume calibration by choosing the calibration screen. The Calibration screen requires a device key to be entered:...
  • Page 45: Main Menu/Adv Settings/Tech Mode/Work Hours

    Ventway Sparrow User Manual The use of fixed volume 500 cc syringe provides an easy and accurate solution for volume calibration. The user must move the syringe handle, completing a cycle in one to two seconds, resulting in an average flow of 15 to 30 lpm. The...
  • Page 46: Main Menu/Adv Settings/Tech Mode/Self Test

    Ventway Sparrow User Manual 10.4.5.4. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST Self Test screen The Self Test screen allows four tests: FLOW AND PRESS – see Section: 10.4.5.4.1 MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /FLOW AND PRESSURE CVT (circuit verification test) – see Section: 10.4.5.4.2 MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /CVT...
  • Page 47: Main Menu/Adv Settings/Tech Mode/Self Test /Flow And Pressure

    Ventway Sparrow User Manual 10.4.5.4.1. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /FLOW AND PRESSURE While the test is in progress, a progress bar displays: Self test progress bar When the test is complete, a test result screen displays: Self test results screen...
  • Page 48: Main Menu/Adv Settings/Tech Mode/Self Test /Cvt

    Ventway Sparrow User Manual 10.4.5.4.2. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /CVT Follow the instructions on the screen for the Circuit Verification Test: CVT screen Use a cap to seal off the patient transducer valve: • Press the navigation knob on the ventilator front panel to begin the test.
  • Page 49: Main Menu/Adv Settings/Tech Mode/Self Test /Vvt

    Ventway Sparrow User Manual 10.4.5.4.3. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /VVT Follow the instructions on the screen for the Ventilator Verification Test: VVT screen In the VVT process, the ventilator is checked for: • System alert – audio • Patient pressure measurement and pressure performance •...
  • Page 50: Main Menu/Adv Settings/Tech Mode/Self Test /Blower Test

    Ventway Sparrow User Manual 10.4.5.4.4. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /BLOWER TEST Follow the instructions on the screen for the Blower Test. Page 50 of 110...
  • Page 51: Main Menu/Adv Settings/Tech Mode/Logbook

    Ventway Sparrow User Manual 10.4.5.5. MAIN MENU/ADV SETTINGS/TECH MODE/LOGBOOK The Logbook screen shows alerts, indications and user interaction with the ventilator: Example of an alert Note: The logbook is displayed in technician mode. Download is possible only in technician mode.
  • Page 52: Main Menu/Adv Settings/Tech Mode/Sw Update

    Ventway Sparrow User Manual 10.4.5.8. MAIN MENU/ADV SETTINGS/TECH MODE/SW UPDATE 10.4.5.9. MAIN MENU/ADV SETTINGS/TECH MODE/SYSTEM MODE 10.4.5.10. MAIN MENU/ADV SETTINGS/TECH MODE/ALTITUDE The altitude above sea level is shown on the bottom of the second Tech Mode submenu. Example of altitude display: 72 meters...
  • Page 53: Warnings And Alerts

    Ventway Sparrow User Manual 11. WARNINGS AND ALERTS This section provides information about alerts, and examples of typical system messages. 11.1. SUMMARY OF ALERT TYPES The following table summarizes the various types of alerts. Alert type Value Range/Display User Respiratory rate...
  • Page 54: Summary Of Alert Levels

    Ventway Sparrow User Manual 11.2. SUMMARY OF ALERT LEVELS Alerts are defined with three levels of importance:  High: Five beeps every two seconds  Medium: Three beeps every five seconds  Low: One beep one time only. Not shown in list of active alerts.
  • Page 55: Warning Example

    Ventway Sparrow User Manual 11.3. WARNING EXAMPLE Here is an example of a warning message: Warning message 11.4. ALERT EXAMPLE A typical alert appears as follows: Example of an alert Note: Press cancel sign (big X) to acknowledge the message and cancel the alert.
  • Page 56: Default Parameters

    12.1.1. OXYGEN SUPPLY When a high-pressure oxygen source that is connected to a demand valve is not available, the Ventway Sparrow ventilator can accept oxygen from a low- pressure oxygen source such as a reservoir bag connected to a flow meter.
  • Page 57: Connecting The Air Inlet To The Demand Valve

    Ventway Sparrow User Manual 12.1.1.1. CONNECTING THE AIR INLET TO THE DEMAND VALVE The oxygen demand valve is connected to the device as shown below. The oxygen demand valve connector is specially threaded to fit securely on top of the air/oxygen inlet.
  • Page 58: Recommended Devices For Monitoring Of Oxygen

    Ventway Sparrow User Manual 12.1.2. RECOMMENDED DEVICES FOR MONITORING OF OXYGEN Company Name Product Model Precision Medical PM5900 Oxygen Monitor Maxtec MaxO ME® ENVITEC MySign®O Caution: Use of the low-pressure oxygen system at concentrations above 60% is NOT recommended, as higher values combined with varying minute volume due to spontaneous breathing of the patient may cause inadvertent PEEP.
  • Page 59: Alert Default Parameters: 5 Kg To 70+ Kg

    Ventway Sparrow User Manual 12.2. ALERT DEFAULT PARAMETERS: 5 KG TO 70+ KG Alert Weight Parameter 10kg 15kg 20kg 30kg 40kg 50kg 60kg 70+ kg Pressure Alert (cm Pressure Limit (cm H High Rate (BPM) Low Rate (BPM) High Min.
  • Page 60: Labels And Symbols

    Ventway Sparrow User Manual 13. LABELS AND SYMBOLS 13.1. LABELS A number of internationally recognized symbols are found on the labels. These relate to safety requirements and standards and are described below. VWSP-100 Civil Model VWSP-900 Military Model Page 60 of 110...
  • Page 61: Symbols

    Ventway Sparrow User Manual 13.2. SYMBOLS The following table explains the meaning of each symbol on the label. Symbol Meaning Consult instructions for use Manufacturer European approval mark Authorized representative in the European Community Serial Number Catalogue number Batch code...
  • Page 62: Cleaning And Disinfecting

    Ventway Sparrow User Manual 14. CLEANING AND DISINFECTING Caution: The system is approved for IP45 in operation mode with oxygen enrichment. To avoid damage to the instrument or patient cable, be careful of liquid spillage while cleaning. Caution: Do not expose the instrument, patient cable or sensors to sprays, or any other type of solvents.
  • Page 63: Ventilation Methods

    Ventway Sparrow User Manual 15. VENTILATION METHODS 15.1. SIMV-VC (PS)FLOW CHART In SIMV-VC, the patient is supplied with the set tidal volume VT during the mandatory breaths. The mandatory breaths are synchronized with the patient’s own breathing attempts. Mandatory breaths are prevented from being applied during spontaneous expiration, by providing that a patient- triggered mandatory breath can only be triggered within a trigger window.
  • Page 64 Ventway Sparrow User Manual 6. If no spontaneous breathing attempt is detected during the inspiratory trigger window, the machine-triggered mandatory breath is applied. The mandatory tidal volume (VT) results from the pressure difference between PEEP and Pinsp, the lung mechanics and the breathing effort of the patient.
  • Page 65 Ventway Sparrow User Manual Note: Through the entire ventilation cycle, we need to test that:  The patient is still connected (no de- crease in PEEP pressure)  Expiratory flow is undisturbed (pressure has decreased – nothing is blocking the ex.
  • Page 66: Cpap - Spontaneous Breathing Mode

    Ventway Sparrow User Manual 15.2. CPAP – SPONTANEOUS BREATHING MODE During the spontaneous ventilation modes, the patient carries out the majority of the breathing effort. The pressure support ventilation level PS can be adjusted. The default PSV level is 18 cm H As long as the patient’s airways are below the PEEP + PSV level, the ven-...
  • Page 67 Ventway Sparrow User Manual Page 67 of 110...
  • Page 68 Ventway Sparrow User Manual CPAP Backup ventilation Note: BPM is based on patient weight and other parameters. Page 68 of 110...
  • Page 69: Backup Ventilation Mode

    Ventway Sparrow User Manual 15.3. BACKUP VENTILATION MODE Note: Backup will not occur when the user inserts weight, selects a ventilation mode and does not press OK. In this situation, a trig- ger is received from the patient and the respiration is performed according to the ventilation mode.
  • Page 70: Backup Ventilation Before Starting Patient Ventilation

    Ventway Sparrow User Manual  Ventilation method is changed to SIMV - VC - PS with the last patient weight parameters dialed in.  BPM value is patient weight based.  Resuming to CPAP ventilation will be possible either by patient trigger (will alert on screen: "CPAP ventilation resumed"...
  • Page 71 Ventway Sparrow User Manual 4. After 3 breaths, the patient weight is evaluated by using TV average of the last 3 breaths: TV[cc] Patient weight [kg] 50-70 71-140 141-210 211-280 281-420 421-560 561-700 701-840 Over 841 5. Evaluating patient weight will establish the other ventilation par- ameters as per a more complete table given in the URS/SRS, including maximum TV, BPM etc.
  • Page 72: Simv Vc (Cpr)

    Ventway Sparrow User Manual 15.4. SIMV VC (CPR) In SIMV-VC (CPR), as in the normal SIMV-VC (PS), the patient is supplied with the set tidal volume VT during the mandatory breaths. The only difference in this setup, is that patient triggering is switched to OFF.
  • Page 73: Cpap (Cpr)

    Ventway Sparrow User Manual 15.5. CPAP (CPR) This setup delivers constant pressure into the patient airways as in the regular CPAP ventilation method, but without any pressure support during triggers (no response to spontaneous breaths). Constant pressure values can be set between 5 to 10 cm H2O, without activation of triggers.
  • Page 74: Service And Maintenance

    Inovytec Medical Solutions Ltd. must not open the Ventway Sparrow device under any circumstances. Opening the Ventway Sparrow device may damage the unit and will void the warranty provided by Inovytec Medical Solutions Ltd. The system requires maintenance on a routine basis of 15,000 operation hours or three years (whichever is first).
  • Page 75: Troubleshooting

    Ventway Sparrow User Manual 17. TROUBLESHOOTING The following table lists some typical conditions that may occur when using the system. Condition Possible Cause Recommended Action Battery disconnected Not inserted Firmly insert battery in its properly place DC connector connected Power supply not...
  • Page 76: Specifications

    Ventway Sparrow User Manual 18. SPECIFICATIONS 18.1. DIMENSIONS AND WEIGHT Width 165 mm Length 167 mm Height 60 mm Weight Civilian version: 1 kg with batteries Military version: 1.3 kg with batteries Page 76 of 110...
  • Page 77: Environmental Specifications

    Max acoustic energy level 55 [dBa] 18.3. HARSH ENVIRONMENTAL CONDITIONS The Ventway Sparrow is designed to operate in extreme environments, such as ground and transport. The Ventilator continuously monitors the ambient pressure, temperature and other parameters, and compensates for these changes.
  • Page 78: Operation In High Or Low Altitude

    18.3.2. OPERATION IN HIGH OR LOW ALTITUDE The Ventway Sparrow is designed to operate at an altitude of -370 to 4,500 meters (-1,200 to 15,000 feet). An internal altimeter measures the ambient pressure, allowing the ventilator to compensate the flow calculations for the changes in density and pressure.
  • Page 79: Power Supply

    Ventway Sparrow User Manual 18.4. POWER SUPPLY External AC-DC Adapter Input 100 to 264 VAC, 50-60 Hz, max 1.6 A Output 16-24 VDC , 120 W Internal Battery 8 x CR123 cells for 12VDC configuration (2 x 4S1P) 4 x 18650 Li-Ion for 14.8VDC rechargeable...
  • Page 80: Ventilation Performance

    Ventway Sparrow User Manual 18.5. VENTILATION PERFORMANCE Note: Measurement accuracy of calibration equipment may affect the respiratory parameters display by the following parameters: Volume calculation : +/-2% or 20 [cc]  Inspiratory and expiratory times : +/- 0.02 [s] ...
  • Page 81: Standards And Safety Requirements

    Ventway Sparrow User Manual 18.6. STANDARDS AND SAFETY REQUIREMENTS The Ventway Sparrow meets the requirements of the following inter- national standards: IEC 60601-1 Medical electrical equipment — Part 1: General requirements for basic safety and essential per- formance IEC 60601-1-2 Medical electrical equipment —...
  • Page 82: Cleaning And Routine Maintenance

    Ventway Sparrow User Manual 19. CLEANING AND ROUTINE MAINTENANCE Part Procedure Comments Ventilator 1. Spray entire Do not allow liquid to surface with 70% penetrate into the ven- Alcohol tilator. 2. Do not wipe Inspect for residual de- device for 1 min.
  • Page 83: Batteries

    Ventway Sparrow User Manual 20. BATTERIES The Sparrow can be configured with two battery options: an internal, re- chargeable, battery pack, and a rechargeable battery pack. The battery should be charged or replaced when not in use. For long storage periods, the battery should not be inserted into the battery compartment of the ventilator.
  • Page 84: Parts And Accessories

    This Section outlines information for ordering and shipment of replace- ment parts for the Ventway Sparrow. All equipment and accessories are available directly from Inovytec Medical Solutions Ltd. or from an authorized distributor. For a list of Inovytec Medical Solutions Ltd. distributors please visit our web site at sales@Inovytec.com.
  • Page 85: Regulatory

    Ventway Sparrow User Manual 22. REGULATORY Manufacturer: Inovytec Medical Solutions Ltd. 3 Hanagar St., POB 7282, Hod-Hasharon 4501306, Israel Tel: +972 9 7794135 E-mail: Info@Inovytec.com Web Site: http://www.Inovytec.com Européen Agent Information: OBELIS S.A. Bd Général Wahis, 53 B-1030 Brussels Belgium...
  • Page 86: Warranty

    If shipping the device is required, pack the device and its accessories carefully to prevent shipping damage. Duration Inovytec Medical Solutions Ltd. will repair or replace, at its sole discretion, the product or any defective part, provided it is returned to Inovytec Medical Solutions Ltd. service within 30 days.
  • Page 87: Appendix - Test Alerts

    Ventway Sparrow User Manual 24. APPENDIX – TEST ALERTS The following instructions explain how to test all the alerts that can be activated by the system, to ensure that they are working properly. 24.1. BACKUP VENTILATION Step Procedure Action Expected Results Start a new patient Message requesting to disconnect the patient.
  • Page 88: Start Backup Ventilation With Unknown Weight

    Ventway Sparrow User Manual 24.2. START BACKUP VENTILATION WITH UNKNOWN WEIGHT Step Procedure Action Expected Results Start a new patient Message requesting to disconnect the patient. via the menu. Set the lung simulator simulated weight to 70 kg. Generate inhalation The software switches to the running ventilation screen trigger.
  • Page 89: Cpap Ventilation With Backup Ventilation

    Ventway Sparrow User Manual 24.3. CPAP VENTILATION WITH BACKUP VENTILATION Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 90: Patient Disconnect

    Ventway Sparrow User Manual 24.4. PATIENT DISCONNECT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 91: High Peep

    Ventway Sparrow User Manual 24.5. HIGH PEEP Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 92: Valve Blocked

    Ventway Sparrow User Manual 24.6. VALVE BLOCKED Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 93: Pressure Alert

    Ventway Sparrow User Manual 24.7. PRESSURE ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 94: Minute Volume (Mv) Alert

    Ventway Sparrow User Manual 24.8. MINUTE VOLUME (MV) ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 95: Leak Alert

    Ventway Sparrow User Manual 24.9. LEAK ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 96: Tidal Volume Alert

    Ventway Sparrow User Manual 24.10. TIDAL VOLUME ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 97: I:ealert

    Ventway Sparrow User Manual 24.11. I:E ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 98: Apnea Alert

    Ventway Sparrow User Manual 24.12. APNEA ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 99: Power Alert

    Ventway Sparrow User Manual 24.13. POWER ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 100: Low Battery Alert

    Ventway Sparrow User Manual 24.14. LOW BATTERY ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 101: Battery Type Alert

    Ventway Sparrow User Manual 24.15. BATTERY TYPE ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 102: Voltage Alert

    Ventway Sparrow User Manual 24.16. VOLTAGE ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 103: Temperature Alert

    Ventway Sparrow User Manual 24.17. TEMPERATURE ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 104: Tube Disconnect Alert

    Ventway Sparrow User Manual 24.18. TUBE DISCONNECT ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 105: Service Required Alert

    Ventway Sparrow User Manual 24.19. SERVICE REQUIRED ALERT Step Procedure Action Expected Results Edit the file WH.txt on the SD-card with value 0 Start up the Sparrow The software indicate that a service is required. ventilator. Silence the alert. Start up the Sparrow The software switches to the ventilation phase, weight ventilator.
  • Page 106: Filter Replacement Required

    Ventway Sparrow User Manual 24.20. FILTER REPLACEMENT REQUIRED Step Procedure Action Expected Results Edit the file WH.txt on the SD-card with value 882000. Start up the Sparrow The software indicate that a filter replacement is required. ventilator. Silence the alert.
  • Page 107: Altitude Change Alert

    Ventway Sparrow User Manual 24.21. ALTITUDE CHANGE ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 108: Shutdown Alert

    Ventway Sparrow User Manual 24.22. SHUTDOWN ALERT Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set. The blower starts.
  • Page 109: Ventilation During Standby (Due To Patient Inspiratory Effort)

    Ventway Sparrow User Manual 24.23. VENTILATION DURING STANDBY (DUE TO PATIENT INSPIRATORY EFFORT) Step Procedure Action Expected Results Start up the Sparrow The software switches to the ventilation phase, weight ventilator. selection screen. Complete the patient circuit test. Set the simulator to Mode is set.
  • Page 110: Appendix - Menu Hierarchy

    Ventway Sparrow User Manual 25. APPENDIX – MENU HIERARCHY The diagram below shows all the menus in the Ventway Sparrow system. Page 110 of 110...

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